Table 2.
Dose level | AR-42 dose (mg) | No. of patients enrolled (N=17) | No. of dose delays | No. of dose reductions | No. of patients with a DLT | Description of DLT |
---|---|---|---|---|---|---|
1A | 30 | 3 | 0 | 0 | 0 | --- |
2A | 60 | 2a | 0 | 0 | 0 | --- |
1B | 60 | 7b | 4 | 2 | 1 | Thrombocytopenia (grade 3) |
2B | 80 | 2c | 0 | 0 | 1 | Thrombocytopenia (grade 3)d Psychiatric disorder (grade 4)d |
Expansion cohort | 60 | 3 | 0 | 0 | --- |
Grade 2 thrombocytopenia experienced by second patient, so advanced to stage B.
Includes 2 cohorts of 3 patients, plus one patient to replace a patient who was non-compliant and not evaluable.
First patient withdrew after 2 doses due to progression and was replaced. Second patient experienced a DLT.
Grade 3 thrombocytopenia and grade 4 psychiatric disorder at dose level 2B occurred in the same patient, counting as one DLT.